Abbott Doubled Niaspan U.S. Sales Before Trials Cut Use

By Drew Armstrong -
Jun 10, 2013

Abbott Laboratories (ABT) aggressively
promoted its Niaspan cholesterol treatment, almost tripling U.S.
use of the medication, in the seven-year period before studies
in 2011 found the drug ineffective, a study found.

From 2002 to 2009, niacin and its brand-name counterpart
Niaspan, now sold by Abbott’s spinoff company AbbVie Inc. (ABBV), rose
191 percent in the U.S., to 696,000 prescriptions a month. A
combination of assertive marketing and stronger medical
guidelines for reducing cholesterol levels drove that increase,
according to research published today in the journal JAMA
Internal Medicine.

Abbott and AbbVie boosted Niaspan prices to almost
completely offset prescription numbers that fell starting in
2011, according to sales data compiled last month by Bloomberg.
Two studies released then and in 2012 found the medicine didn’t
help patients and may have hurt them. Price increases helped
AbbVie hold on to revenue from the drug even as evidence against
it mounted.

“Some of it was the advertising, another, especially in
the U.S., was that the guidelines for cholesterol have been a
little more aggressive in terms of decreasing LDL,” or bad
cholesterol, said Cynthia Jackevicius, the study’s lead author
and a professor at Western University in Pomona, California.

Niacin, a form of vitamin B3, has been around since 1956 as
a treatment for patients whose bad cholesterol is too high. Side
effects to the drug, noted on its label, include red skin rashes
and itching. Abbott bought the brand version Niaspan in 2006
when it acquired Kos Pharmaceuticals for $3.4 billion.

Niaspan Sales

Approved for sale in the U.S. in 1997, Niaspan generated
$5.11 billion in sales for Abbott through 2012. Last year it was
Abbott’s sixth-biggest product, with $911 million. Since the
negative 2011 study, monthly Niaspan prescriptions have fallen
by about 33 percent as of April, according to data compiled by
Bloomberg.

U.S. cholesterol guidelines, published by the National
Institutes of Health, were updated in 2001. They called for
higher good cholesterol and for lowering multiple types of bad
cholesterol, compared to previous guidelines. Niaspan was used
along with drugs like Pfizer Inc. (PFE)’s Lipitor and Merck & Co.’s
Zocor as a way of “driving down the numbers if you couldn’t do
it with a statin” alone, said David Frid, a physician with the
Cleveland Clinic’s preventative cardiology department.

Abbott’s extended-release version of the medicine also cut
down on side effects like flushing, Frid said, making doctors
more likely to use it.

“There was the continued belief that raising HDL had a
clinical benefit, there was the focus on non-HDL cholesterol
lowering and there was the availability of a form of niacin that
made the side effects not as bad,” Frid said in a telephone
interview. “Those were the things that drove it.”

Prescription Growth

The increase in niacin use was pronounced in the U.S. The
research also found that the number of prescriptions in America
was six times as great as in Canada in 2009. Canada also has
more restrictive laws on drug advertising. Most of the growth in
niacin use was from Abbott’s Niaspan, which is an extended-release version of the drug, according to the study.

The company’s television and online ads, said that the drug
can help raise HDL levels, cut the risk of heart attacks and
slow the build-up of arterial plaque. Because the medicine has
been approved for decades in its generic form of niacin, though,
it hadn’t been the focus of any recent major trial.

“New prescriptions, and prescriptions for niacin in
general, were increasing in both countries despite no new
evidence,” Jackevicius said in a telephone interview.

AbbVie Spinoff

AbbVie, based in North Chicago, Illinois, was spun off from
Abbott at the start of this year into a drugs-only business.
Abbott, meanwhile, continues to operate the company’s device,
diagnostic and nutrition units. AbbVie has called Niaspan an
important treatment option, despite the studies that show no
heart benefit from the medicine.

Other experimental treatments that have tried to
artificially raise good cholesterol levels haven’t proved
effective. Trials of Pfizer’s good-cholesterol raising drug
torcetrapib were halted in 2006 over safety concerns.

Doctors seek to lower bad cholesterol and raise good
cholesterol to cut the risk of heart disease. That can be
accomplished through drugs, diet, and exercise.

“By having a secondary target, it may have prompted some
physicians to use niacin to reach those goals, rather than
thinking about the clinical goals,” she said. “It just hasn’t
translated, in the populations it’s been studied in, into
improved clinical outcomes.”